EXIT: Prospective Study of the Response to Exercise

Background :

Regular exercise is a cornerstone in the prevention and the management of comorbidities. Unfortunately, the metabolic benefit of exercise training is not universal and varies among individuals. A main factor likely to explain the exercise training variability is the lack of empirical evidence on the determinants of exercise training. A series of muscle-derived cytokines have recently been discovered that (1) are released during exercise and (2) exert positive effects on peripheral tissues. Irisin is one of these novel "myokines" and might contributes to the metabolic adaptations to exercise training.

Methods:

The investigators will perform a pilot cohort study in which obese adolescents will perform resistance exercise training for 6 weeks. The main exposure variable will be the acute release of irisin during resistance exercise. The main outcome measures will be the change in hepatic triglyceride content and glucose area under the curve during a 75g, 2-hour oral glucose tolerance test.

Study Hypothesis:

The primary overall hypothesis is that the change in plasma Irisin with a single bout of exercise will be associated with the metabolic adaptations to 6 weeks of resistance training, specifically, the reductions in hepatic triglyceride content and post-prandial glucose excursions, in obese adolescents.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Liver Fat Behavior Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Liver Diseases Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Manitoba Institute of Child Health

Winnipeg, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adolescents (12-18 years)
Body mass index considered obese according to the International Obesity Task Force

Exclusion criteria

Adolescents with medication-induced or type 1 diabetes
are currently being treated with corticosteroids or atypical antipsychotics, as these agents significantly influence carbohydrate metabolism
have an orthopaedic injury or chronic illness that would prevent them from performing the intervention
have experienced >10% weight loss or enrolled in weight loss program within six months of enrolment
a history of alcoholism or drug abuse
require use of medication(s) known to affect insulin sensitivity or secretion within the last 30 days
medication(s) known to cause weight gain
anabolic steroids
weight loss medication(s)
pregnant or planning to be pregnant

Treatment and study plan

Acute release of irisin after a single exercise session.

Other

We will determine the amount of Irisin secreted after a single bout of resistance exercise. Participants will be stratified into 3 groups based on the degree of Irisin release during this acute bout of resistance exercise. The metabolic adaptations to the 4 weeks of resistance training will be compared between youth stratified according to the amount of Irisin released during the acute bout of resistance exercise.

Primary outcomes

Hepatic Triglyceride Content

Time frame: 6 weeks

Hepatic triglyceride content will be measured by using 1H magnetic resonance spectroscopy. After image acquisition, a single voxel volume of interest will be placed in the upper right lobe of the liver in an area devoid of adipose tissue to acquire 1H spectra. A total of 64 spectra will be collected and averaged to determine the intracellular triglyceride content.

Secondary outcomes

Post-prandial glucose

Time frame: 6 weeks

Glucose area under the curve (AUC) will be determined by summing the area under serum glucose measures between each 15- or 30-min segment using the trapezium rule during a frequently sampled 75-g oral glucose challenge .

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

Exercise and Irisin Trial (EXIT): Prospective Cohort Study of the Determinants of the Metabolic Response to Exercise in Obese Adolescents

Acronym: EXIT

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jul 30, 2014
Registry last updated: Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed